Class 2 Device Recall Proteus 235

• Date Initiated by Firm: April 21, 2020
• Create Date: August 07, 2020
• Recall Status: Terminated on September 01, 2021
• Recall Number: Z-2773-2020
• Recall Event ID: 86073
• 510(K)Number: K163500
• Product Classification: System, radiation therapy, charged-particle, medical - Product Code LHN
• Product: Proteus 235; The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
• Code Information: Serial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019 SBF.113 (US): manufactured June 2019 SBF.117 (EU): manufactured November 2019
• Recalling Firm/ Manufacturer: Ion Beam Applications S.A.; Chemin Du Cyclotron 3; Louvain-la-neuve Belgium
• For Additional Information Contact: Sylviane Berger; 32-478-887029
• Manufacturer Reason for Recall: Signature from the user is necessary to proceed with specific actions in the Proton Therapy System (PTS). IBA became aware that the PTS does not accept user names with more than ten characters. It is an issue when the user has no other choice than resuming an aborted treatment field based on the overall delivered dose displayed on the Dose Counter Electronic Unit (DCEU). User s signature is required to perform this action. If the signature contains more than ten characters, the user will not be able to complete the aborted treatment field. An additional issue applies to Electronic Medical Record (EMR) centric sites and may increase the probability of not being able to complete an aborted treatment field. It is not possible, in a new session, to resume from a local partial archive if the Patient Positioning System (PPS) position has changed. If the user captures the PPS position at every session in the Oncology Information System (OIS) just after the setup process, the prescribed PPS position is changed for the next session in the OIS. This includes the partial continuation session. Therefore, when comparing the prescribed PPS position between OIS and local database, the PTS sees a difference and rejects the local partial archive. This problem forces the user to resume the interrupted irradiation based on the overall delivered dose displayed on the DCEU instead of resuming from the full details of the interrupted beam.
• FDA Determined Cause: Software design
• Action: IBA sent a customer communication letter dated May 8, 2020. This letter explained to the customers, it is recommended to redefine any user name that contains more than ten characters to a user name with up to ten characters. Software upgrade IBA will remove the limitation on the allowed length of the user name in the database. IBA will modify the list of criteria that guarantee proper matching between the treatment field being resumed and the treatment field that was interrupted: patient position from the beam report will be used instead of the PPS position. The solutions will be deployed on your site by February 1, 2021.
• Quantity in Commerce: 4 units
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of FL, VA and the countries of Belgium, Spain.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LHN and Original Applicant = Ion Beam Applications S.A.